Woodstock Sterile Solutions is a leading blow-fill-seal (BFS) contract development and manufacturing organization (CDMO), providing best-in-class sterile development and manufacturing solutions across a broad—and growing—range of products. The company was established roughly one-year ago on March 31, 2021, when it was purchased by SK Capital from Catalent Pharma Solutions, including its site in Woodstock, Illinois, which has been in operation serving the pharma industry for more than 40 years. At the time of the acquisition, SK appointed Paul Josephs as CEO to lead the organization during its spin-out from Catalent, as it transitioned to operate as an independent company under its own brand identity.

A 30-year veteran of the pharma industry, with 25-years in the CDMO sector, Josephs was at the time SK came calling, head of contract development and manufacturing and global business development at Mylan, a global generic and specialty pharmaceuticals company. Before that he held several leadership roles at another CDMO, DPT Laboratories. With approximately 450 employees and operating in excess of a $100 million in revenue, Josephs said he saw incredible potential in Woodstock when he was contacted about becoming its chief executive, calling the business a “sleeping giant.” In fact, in just its first year out of the gate, Woodstock has managed to add double-digit customer programs to its pipeline, and continues to grow. Contract Pharma had the chance recently to talk with Josephs about his experience since taking the helm.

Contract Pharma: It’s been about a year since you were named CEO of Woodstock. What has struck you most about the business so far?

Paul Josephs: What I’ve seen is that there’s a tremendous amount of talent at this site. We have a strong group of individuals that work very well together for the betterment of the business. The team is really committed to delivering for our customers and we’ve seen this manifest further through the addition of a strong business development team. Also, I’ve been very impressed with the level of technical expertise on display throughout the company.

CP: Since spinning out from Catalent, what have been some of the challenges Woodstock has faced going on its own?

Josephs: Spinning a business out of a large multi-national has definitely presented challenges. Whether it’s carving out normal infrastructure applications while also trying to run the business with the same resources, has been a bit of a challenge for us and is something we’re working through. SK has a great playbook for executing against these and we’re using that to our advantage to hit all the appropriate milestones.

Another obstacle has been operating during the midst of a pandemic—integrating and building out a team that’s socially distant and working remotely with limited travel. That’s been a bit of a challenge, but we’ve been successful in working through it, accomplishing goals and building a company culture. The great thing is there’s such a commitment to our customers and the patients they serve at this site, this is consistent with the culture that I wanted to try and build.

CP: What is unique about Woodstock as a drug development and manufacturing partner organization in the CDMO space?

Josephs: Well, certainly with regards to the services that we provide, based on the feedback that I’ve received from our customers and the programs that we’re working on, Woodstock is looked at as being a technical leader in its ability to solve complex formulation problems, or development problems in general. Relative to what I’ve seen in the industry, we’ve been able to solve development issues—both formulation and process problems—for sponsors that weren’t successful with their other partners. I see that as a unique element of the business and it’s something that we’re looking to continue to augment and build out as part of our future plans.

CP: What are some of Woodstock’s business highlights from the past year?

Josephs: Well, first of all, we set out with some strong goals and we’re on track to meet all those, specifically on the financial side. One thing I’ve seen working in the CDMO industry is you set out with a dynamic game plan at the start of the year and it never turns out exactly how you think it’s going to when you put that plan in place. I’m proud of our team for adapting and being on track to meet not only our financial goals, but also our service, quality and safety goals as well.

We’re also on track to add double-digit programs within a year of establishing the business, which to me is impressive since it’s only been a short time since the company was established as Woodstock Sterile Solutions. It tells you that, first of all, there’s a strong legacy of excellence at the Woodstock site, and second, there’s clearly a need within the industry that we’re fulfilling.

CP: What are some plans and goals for the business in the near- and long-term?

Josephs: First and foremost, from a business perspective, we want to be recognized as the leading provider of BFS services in the industry by providing the best service to our customers. We’re focused on delivering on our current pipeline while at the same time, through strong business development efforts, will be looking to continue to add additional programs each and every year in addition to the double-digit programs already in place.

Near-term, we’re in the middle of a multi-million-dollar lab expansion (see side bar on page 34), which will allow us to provide full-service quality control services to our customers. In addition, complementing this lab expansion we will move toward providing expanded development capabilities, including formulation and method development capabilities. So, that’s impactful and we’re excited about the lab expansion, which will be completed early in 2023.

We’re also embarking on the addition of more BFS capability and capacity through the procurement of a new BFS machine, which is a multi-million-dollar investment. We’ll also be announcing in the next couple of months a long-term capital plan, which will be in excess of $20 million dollars.

CP: What are some of the broader pharma trends that are impacting the CDMO space in general?

Josephs: Certainly, a major trend is the continued emergence of more large molecules—large molecule manufacturing focused on biologics is a big push. I also think there’s an increased focus on the generics space, brought on by changes in regulations. Also, speed has always been important within our industry, but I think that now it’s even more paramount. How do we bring products to market quicker? Specifically with your small and specialty pharmaceutical companies. I think growth in the CDMO sector is going to continue to be healthy because of these factors.

CP: What are some of the bigger challenges service providers face in the years ahead?

Josephs: One word: Talent. Retaining it, developing it and recruiting it. We have an exciting future with our current pipeline and the programs we’re bringing in, and we have a great team. But it’s going to be our ability to retain that team and then continue to add A-level talent as needed. This will be critical to our future success at Woodstock, and also for other service providers across the pharma landscape.

In addition, from a compliance perspective, the FDA is dynamic and there’s emerging compliance regulations that we need to stay up to speed with, ensuring that we are able to meet guidelines so that our customers continue to outsource to Woodstock with confidence.

CP: How has the COVID pandemic impacted the regulatory environment?

Josephs: I think that from an audit perspective, there’s been a slowdown for sure. The FDA has not been ‘on the road’ as they have in the past, decreasing the number of on-site audits. As a result, at least from my perspective, there’s been a slowdown in the approval of products requiring a pre-approval inspection. But we’re coming out of this situation, so I think we’ll start to see some of these approvals that have been backlogged, start to break through.

CP: When sponsors come to Woodstock, what are their concerns when deciding whether or not to begin a partnership?

Josephs: This question reminds me of a customer I encountered early in my career with DPT that said, “Paul, what we look for in a contract manufacturer is not just the pair of hands, but we look for the brain as well.” While this might sound funny, I don’t think it’s ever been truer than now. That is what customers look for in a service provider, not only the ability to manufacture a product, but to solve complex problems. To really act as a value-added partner to the customer, that is the key. And, I think that’s where we at Woodstock have the opportunity to really differentiate ourselves through our technical expertise and service. Having the ability to solve complex problems is what our customers look for, and why we’ve been able to add double-digit programs this year. At Woodstock the customer sees not only a pair of hands, but a brain as well.